Label: MAXIMUM STRENGTH GAS RELIEF- simethicone capsule, liquid filled

  • NDC Code(s): 11673-827-30, 11673-827-76
  • Packager: TARGET CORPORATION
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 13, 2024

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each softgel)

    Simethicone 250 mg

  • PURPOSE

    Purpose

    Antigas

  • INDICATIONS & USAGE

    Use for the relief of

    • pressure, bloating, and fullness commonly referred to as gas
  • Warning

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime
    • do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician
  • STORAGE AND HANDLING

    Other information

    • store at room temperature
    • protect from light, heat and moisture
  • INACTIVE INGREDIENT

    Inactive ingredients

    D&C red no. 33, FD&C blue 1, gelatin, glycerol, medium chain triglyceride, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

  • QUESTIONS

    Questions or comments? Call 1-800-910-6874

  • PRINCIPAL DISPLAY PANEL

    simethicone-250mg-50s-label728T-TG-Simethicone-30-IFC

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-827
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE250 mg
    Inactive Ingredients
    Ingredient NameStrength
    SORBITAN (UNII: 6O92ICV9RU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SHELLAC (UNII: 46N107B71O)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 119
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-827-303 in 1 CARTON08/23/2023
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11673-827-765 in 1 CARTON05/15/2024
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00208/23/2023
    Labeler - TARGET CORPORATION (006961700)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(11673-827)
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